(a) Identification. A hand-held internal therapeutic massager device is a prescription device intended for medical purposes to manually provide direct pressure applied to localized areas of pain or tenderness in the myofascial tissue associated with chronic pelvic pain syndromes. The device is inserted rectally or vaginally and provides quantitative feedback to the user of the applied force to the target tissue.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Labeling must include adequate directions for use.

(2) Non-clinical performance testing must demonstrate electromagnetic compatibility (EMC), electrical safety and mechanical safety.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Mechanical durability; and

(ii) Accuracy of the feedback mechanism.

(4) Software verification, validation, and hazard analysis must be performed.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

[84 FR 57323, Oct. 25, 2019]